Centers for Disease Control and PreventionCenter for Preparedness and Response

What Clinicians Need to Know About Johnson & Johnson’s Janssen COVID-19 Vaccine

Clinician Outreach and Communication Activity (COCA) Webinar

Tuesday, March 2, 2021

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Today’s Presenters▪ Sarah Mbaeyi, MD, MPH

CDR, U.S. Public Health ServiceMedical OfficerNational Center for Immunization and Respiratory DiseasesCenters for Disease Control and Prevention

▪ Sara Oliver, MDLCDR, U.S. Public Health ServiceCo-lead, Advisory Committee for Immunization Practices COVID-19 Vaccines Work GroupCOVID-19 ResponseCenters for Disease Control and Prevention

▪ Kathleen Dooling, MD, MPHMedical OfficerCo-lead, Advisory Committee for Immunization Practices COVID-19 Vaccines Work GroupCOVID-19 ResponseCenters for Disease Control and Prevention

For more information: www.cdc.gov/COVID19

What Clinicians Need to Know about Johnson and Johnson’s Janssen COVID-19 vaccine

ACIP COVID-19 Vaccines

Sara Oliver MD, MSPH

Sarah Mbaeyi MD, MPH

Kathleen Dooling MD, MPH

March 2, 2021

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Outline:

1) Safety and efficacy of Janssen COVID-19 vaccinesDr. Sara Oliver

2) Clinical considerations for use of Janssen COVID-19 vaccineDr. Sarah Mbaeyi

3) Implementation considerations for Janssen COVID-19 vaccineDr. Kathleen Dooling

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Safety and Efficacy of Janssen COVID-19 vaccines: Data from Phase III clinical trial

▪ The clinical trial demonstrated efficacy against symptomatic, laboratory-confirmed COVID-19. The overall efficacy was 66.3% (95% CI: 59.9%, 71.8%).

▪ For COVID-19 associated hospitalization, 31 events occurred, 29 in the placebo group, 2 in the vaccine group. Vaccine efficacy against hospitalization was 93% (95% CI: 71%, 98%).

▪ For all-cause deaths, 5 occurred in the vaccine group and 20 in the placebo group. Vaccine efficacy against all-cause death was 75% (95% CI: 33%, 91%)

Summary of the Available Evidence: Vaccine Efficacy

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▪ Preliminary data were available to assess vaccine efficacy against seroconversion between days 29 and 71, based on the first 7% of specimens tested.

▪ Analysis was based on detection of N-binding antibody among persons who remained asymptomatic and did not have a positive SARS-CoV-2 PCR at any time in the study.

▪ Between four and ten weeks after vaccination with the Janssen COVID-19 vaccine, 10/1346 participants (0.7%) seroconverted, compared to 37/1304 (2.8%) of those receiving placebo. Vaccine efficacy against seroconversion was 74% (95% CI: 48%, 87%).

Summary of the Available Evidence: Vaccine Efficacy

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▪ Similar efficacy for across age, sex, race, and ethnicity categories, and those with underlying medical conditions at ≥14 days post-vaccination

64.7

76.5

66.4

65.6

67.6

63.7

64.2

67.6

0 20 40 60 80 100

Vaccine Efficacy (%)

Summary of the Available Evidence: Vaccine Efficacy

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Age 18-64 years

Age ≥65 years

Non-Hispanic/Latino

Hispanic/Latino

White

Black

With comorbidities

Without comorbidities

Summary of the Available Evidence: Vaccine Efficacy

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▪ Higher efficacy against severe outcomes than for any symptomatic COVID-19*

– VE against deaths due to COVID-19: 100%

▪ Efficacy estimates for severe outcomes assessed ≥28 days post vaccination were higher: 83.5% for severe disease†, 100% for hospitalization

▪ Efficacy against severe disease† remained high across world regions (73-82%*), suggesting protection against severe illness with variant strains

†Definition: Respiratory Rate ≥ 30, Heart Rate ≥125, SpO2≤ 93% on room air at sea level or PaO2/FIO2< 300 mm Hg; OR respiratory failure or Acute Respiratory Distress Syndrome (ARDS), defined as needing high-flow oxygen, non-invasive or mechanical ventilation, or ECMO; OR evidence of shock (systolic blood pressure <90mmHg, diastolic BP<60mmHg or requiring vasopressors); OR significant acute renal, hepatic or neurologic dysfunction; OR admission to an intensive care unit or death*Assessed ≥ 14 days post vaccination

▪ Serious adverse events were reported in a similar proportion among recipients of vaccine and placebo (0.4% vs 0.4%).

▪ Severe reactions were more common in vaccine recipients; any grade ≥3 reaction was reported by 2.5% of vaccinated versus 0.7% of placebo group.

Summary of the Available Evidence: Safety and Reactogenicity

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Summary of the Available Evidence: Safety and Reactogenicity

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▪ Local reactions within 7 days occurred in ~50% vaccine recipients

– Pain at the injection site most common

▪ Systemic reactions within 7 days occurred in ~55% vaccine recipients

–Headache, fatigue, and myalgia most common

▪ Most symptoms resolved after 1-2 days

Summary of Available Evidence: Reactogenicity

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59.8% 58.6%61.5%

12.8%

20.2%17.4%

36.4%

0.7%

35.4%33.3%

45.3%

3.1%

18.3%15.6%

33.1%

0.5%

ANY PAIN ANY FEVER

LOCAL AE, ANY GRADE SYSTEMIC AE, ANY GRADE

REACTOGENICITY BY AGE GROUP, PHASE III TRIAL DATA (N=3356 VACCINE, 3380 PLACEBO)

18-59 years, Vaccine 18-59 years, Placebo ≥60 years, Vaccine ≥60 years, Placebo

Abbreviations, AE= Adverse Events

Summary of Available Evidence: Reactogenicity

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0.9%

0.4%

2.3%

0.3%0.2%

0.0%

0.6%

0.0%

0.4%

0.2%

1.1%

0.1%0.2% 0.2%

0.7%

0.0%

ANY PAIN ANY FEVER

LOCAL AE, GRADE 3 SYSTEMIC AE, GRADE 3

GRADE 3 REACTOGENICITY BY AGE GROUP, PHASE III TRIAL DATA (N=3356 VACCINE, 3380 PLACEBO)

18-59 years, Vaccine 18-59 years, Placebo ≥60 years, Vaccine ≥60 years, Placebo

Abbreviations, AE= Adverse Events

Summary of the Available Evidence: Safety and Reactogenicity

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Adverse event imbalances of note:

▪ Urticaria events: vaccine n=5; placebo n=1

– Possibly related to the vaccine*

▪ Tinnitus: vaccine n=6; placebo n=0

– Insufficient data to determine causal relationship*

▪ Thromboembolic events: vaccine n=15; placebo n=10

– Many of the participants had predisposing conditions. FDA determined contributory effect of vaccine not excluded, insufficient data to determine causal relationship*

– FDA recommends surveillance for further evaluation of thromboembolic events

*Causal determination per FDA

Summary of the Evidence: All authorized COVID-19 vaccines

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▪ No trials compared efficacy between vaccines in the same study at the same time

– All Phase 3 trials differed by calendar time and geography

– Vaccines were tested against different circulating variants and in settings with different background incidence

▪ All authorized COVID-19 vaccines demonstrated efficacy (range 65 to 95%) against symptomatic lab-confirmed COVID-19

▪ All authorized COVID-19 vaccines demonstrated high efficacy (≥89%) against COVID-19 severe enough to require hospitalization

▪ In the vaccine trials, no participants who received a COVID-19 vaccine died from COVID-19

– The Moderna and Janssen trials each had COVID-19 deaths in the placebo arm

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Clinical Considerations for Use of the Janssen COVID-19 vaccine

▪ CDC clinical considerations for mRNA COVID-19 vaccines published previously:– https://www.cdc.gov/vaccines/covid-19/info-by-

product/clinical-considerations.html

▪ Clinical considerations are being updated to include Janssen COVID-19 vaccine– Viral vector COVID-19 vaccine

Clinical considerations for use of mRNA COVID-19 vaccines

18Sign up to receive email updates when clinical considerations are updated: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

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▪ Authorized for persons aged ≥18 years

▪ Intramuscular injection (0.5 ml)

▪ Vaccine shipment and storage (3 months) at refrigerator temperatures (2-8oC)*

▪ Single-dose series

▪ No diluent required

Summary of the Janssen vaccine characteristics

* Long-term storage at standard freezer temperatures (-20oC)

▪ Any COVID-19 vaccine can be used when indicated; no product preference

▪ COVID-19 vaccines are not interchangeable– Safety and efficacy of a mixed series has not been evaluated

▪ If first dose of mRNA COVID-19 vaccine was received but patient unable to compete series with same or different mRNA vaccine – Single dose of Janssen COVID-19 vaccine may be administered at minimum interval of 28

days from mRNA dose*– Considered to have received valid, single-dose Janssen vaccination, not mixed vaccination

series (mRNA/viral vector)

Interchangeability of COVID-19 vaccine products

20*Persons with a contraindication to mRNA COVID-19 vaccines have a precaution to Janssen COVID-19 vaccine. In these patients, vaccination should be undertaken in an appropriate setting under the supervision of a health care provider experienced in the management of severe allergic reactions. Consider referral to allergist-immunologist.

▪ Currently authorized COVID-19 vaccines are all inactivated vaccines

▪ COVID-19 vaccine should be administered alone with minimum interval of 14 days before or after administration of other vaccines

▪ A shorter interval may be used in situations where the benefits of vaccination are deemed to outweigh the potential unknown risks (e.g., tetanus toxoid vaccine for wound management, etc.) or to avoid barriers or delays to vaccination

Coadministration of COVID-19 vaccines with other vaccines

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▪ Any currently authorized COVID-19 vaccine can be administered to persons with underlying medical conditions who have no contraindications to vaccination, including:– Immunocompromised persons– People with autoimmune conditions– People with history of Guillain-Barré syndrome, Bell's palsy, dermal filler use

▪ Clinical trials demonstrate similar safety and efficacy profiles in persons with underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to persons without comorbidities

COVID-19 vaccination of persons with underlying medical conditions

22https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

▪ Persons with HIV infection, other immunocompromising conditions, or who take immunosuppressive medications or therapies might be at increased risk for severe COVID-19

▪ Immunocompromised persons may receive COVID-19 vaccine unless otherwise contraindicated– All currently authorized vaccines are inactivated vaccines

▪ Individuals should be counseled about:– Unknown vaccine safety and efficacy profiles in immunocompromised persons– Potential for reduced immune responses– Need to continue to follow current guidance to protect themselves against COVID-19

COVID-19 vaccination of immunocompromised persons

23https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.htmlhttps://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#phrecs

▪ COVID-19 and pregnancy– Increased risk of severe illness (ICU admission, mechanical ventilation and death)– Might be an increased risk of adverse pregnancy outcomes

▪ Currently limited data on safety of COVID-19 vaccines in pregnant people– No concerns demonstrated in animal developmental and reproductive toxicity (DART) studies– Janssen adenovirus vector platform previously used for other clinical development programs

that included pregnant people, including a large-scale Ebola vaccine trial

▪ Currently authorized COVID-19 vaccines are all inactivated vaccines

▪ Clinical trials to evaluate safety and efficacy of COVID-19 vaccines in pregnant people planned or underway

COVID-19 vaccination of pregnant people

24https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/pregnancy-breastfeeding.htmlhttps://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/special-situations.html

▪ Pregnant people may choose to receive COVID-19 vaccine when eligible

– A conversation between the patient and their clinical team may assist with decision, but is not required

– Conversation should consider:

• Level of COVID-19 community transmission

• Personal risk of contracting COVID-19

• Risks of COVID-19 to patient and fetus

• Efficacy and side effects of vaccine

• Limited data about vaccine during pregnancy

COVID-19 vaccination of pregnant people

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Contraindications and precautions for COVID-19 vaccinesCONTRAINDICATION TO VACCINATION PRECAUTION TO VACCINATION MAY PROCEED WITH VACCINATION

History of the following:

• Severe allergic reaction (e.g., anaphylaxis) after

a previous dose or to component of the

vaccine†

• Immediate allergic reaction* of any severity

after a previous dose or known (diagnosed)

allergy to a component of the vaccine†

Actions:

• Do not vaccinate.

• Consider referral to allergist-immunologist.

• Consider other vaccine alternative.†

Among persons without a contraindication, a history

of:

• Any immediate allergic reaction* to other

vaccines or injectable therapies‡

Actions:

• Risk assessment

• Consider referral to allergist-immunologist

• 30-minute observation period if vaccinated

Among persons without a contraindication or

precaution, a history of:

• Allergy to oral medications (including the oral

equivalent of an injectable medication)

• History of food, pet, insect, venom,

environmental, latex, etc., allergies

• Family history of allergies

Actions:

• 30-minute observation period: persons with

history of anaphylaxis (due to any cause)

• 15-minute observation period: all other

persons

† See Appendix C for a list of ingredients. Persons with a contraindication to one of the mRNA COVID-19 vaccines should not receive doses of either of the mRNA vaccines (Pfizer-BioNTech or Moderna). * Immediate allergic reaction to a vaccine or medication is defined as any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur

within four hours following administration.‡Includes persons with a reaction to a vaccine or injectable therapy that contains multiple components, one of which is a vaccine component, but in whom it is unknown which component elicited the immediate allergic reaction.#Polyethylene glycol (PEG) is an ingredient in both mRNA COVID-19 vaccines, and polysorbate 80 is an ingredient in Janssen COVID-19 vaccine. PEG and polysorbate are structurally related, and cross-reactive hypersensitivity

between these compounds may occur. Persons with a contraindication to mRNA COVID-19 vaccines (including due to a known [diagnosed] allergy to PEG) have a precaution to Janssen COVID-19 vaccine. Among persons who

received one mRNA COVID-19 dose but for whom the second dose is contraindicated, consideration may be given to vaccination with Janssen COVID-19 vaccine (administered at least 28 days after the mRNA COVID-19 dose).

Persons with a contraindication to Janssen COVID-19 vaccine (including due to a known [diagnosed] allergy to polysorbate) have a precaution to mRNA COVID-19 vaccines. In patients with these precautions, vaccination should be

undertaken in an appropriate setting under the supervision of a health care provider experienced in the management of severe allergic reactions. Consider referral to allergist-immunologist.

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Implementation Considerations for Use of the Janssen COVID-19 vaccine

▪ ACIP states no preference for any of the three authorized vaccines

▪ Results of Janssen Phase III trials not comparable with mRNA vaccines– Different calendar time– Different geography

▪ Strong protection against severe COVID-19– 93% VE against hospitalizations (2 cases in vaccinated vs. 29 in placebo)– No COVID-associated deaths in vaccinated vs. 7 in placebo

Janssen COVID-19 Vaccine

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Different circulating variantsHigher background incidence

Janssen COVID-19 VaccineHow does it best fit?

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Characteristics of the vaccine

▪ 1 dose

▪ Transport, and storage (x3m) at 2-8oC

▪ No diluent/reconstitution necessary

Janssen COVID-19 VaccineConsiderations for utilization

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Where?

▪ Mobile/pop-up clinics

▪ Newly established vaccine administration sites

▪ Sites that do not have freezer capacity (e.g. adult HCP offices)

Who?

▪ People who want to be fully vaccinated quickly

▪ People who don’t want to return or can’t return for a second dose

▪ Mobile populations or homebound populations

COVID-19 Vaccine Work Group considerations

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▪ During a pandemic, under EUA, offering Janssen COVID-19 vaccine to persons 18 years and older, according to established allocation and eligibility recommendations in a given jurisdiction, is an effective implementation strategy– Allows for jurisdictional flexibility– Supports rapid vaccination and increases in population immunity– Does not single out any group– Allows individuals to be vaccinated with the earliest vaccine available

For more information, contact CDC1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Thank you

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